Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
19/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NICCO CRCI

Study information

Scientific title

A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Colon, Rectal cancer

Intervention

COLON CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses.

RECTAL CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Radiotherapy 4400 cGy in 22 daily fractions plus adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses. Radiotherapy to be given five days per week prior to or concurrent with chemotherapy.

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil and folinic acid (leucovorin)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 80 years
2. World Health Organisation (WHO) performance status zero to two
3. Histological proof of colorectal adenocarcinoma
4. The entire colorectum must be visualised pre- or postoperatively to exclude synchronous carcinoma
5. Potentially curative surgery
6. Adjuvant treatment to be initiated within six weeks of surgery
7. Adequate bone marrow, renal and hepatic function

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin

Recruitment start date

01/08/2002

Recruitment end date

01/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Wyeth-Lederle Ltd (UK)

Sponsor details

Huntercombe Lane South
Taplow
Maidenhead
Berkshire
SL6 0PH
United Kingdom
-
info@isrctn.com

Sponsor type

Industry

Website

http://www.wyeth.co.uk/

Funders

Funder type

Industry

Funder name

Wyeth-Lederle Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Friends Of Montgomery House (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes